Force Feedback 476205Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00886874125588), received between Nov 7, 2025 and May 5, 2026 — classified as 4 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Break” (6 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryMay 5, 2026Material Separation

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED LOW ANTERIOR RESECTION (LAR) PROCEDURE, A PIECE OF THE DISTAL SHAFT COVERING WAS NOTICED BROKEN OFF FROM A FENESTRATED BIPOLAR FORCEPS (FBF) INSTRUMENT. THE STAFF NOTICED THE ISSUE WHILE EXCHANGING INSTRUMENTS. A FRAGMENT FELL INSIDE THE PATIENT AND WAS REMOVED FROM THE PATIENT DURING THE SAME SURGICAL PROCEDURE WHICH WAS COMPLETED ROBOTICALLY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE FBF INSTRUMENT WAS NOT FOUND TO HAVE ANY DEFECTS PRIOR TO THE CASE. HOWEVER, THE INSTRUMENT BREAKAGE WAS DISCOVERED AFTER REMOVAL OF THE DEVICE FROM THE PATIENT. THE INSTRUMENT APPEARED TO FUNCTION PROPERLY DURING THE CASE. A LARGE FRAGMENT FELL INSIDE THE PATIENT BUT WAS RETRIEVED USING A LAPAROSCOPIC INSTRUMENT. ALL PIECES WERE CONFIRMED INTACT BY RECONSTRUCTING THEM ON THE BACK TABLE. NO ADDITIONAL SURGERY, IMAGING, OR CONVERSION FROM ROBOTIC TECHNIQUE WAS NEEDED, AND NO INJURY OR POST-SURGICAL COMPLICATIONS OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25087354 ↗
• MalfunctionApr 27, 2026Break

  IT WAS REPORTED THAT THE FORCE FEEDBACK FENESTRATED BIPOLAR FORCEPS INSTRUMENT WAS BROKEN. THE PROCEDURE WAS COMPLETED WITH NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24994237 ↗
• MalfunctionApr 24, 2026Break

  IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE INSTRUMENT END PIECE WAS CRACKED. THERE WAS NO REPORT OF PATIENT INVOLVEMENT OR REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24990562 ↗
• MalfunctionApr 13, 2026Material Fragmentation

  IT WAS REPORTED THAT PRIOR TO STARTING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THERE WAS A SPLINTER ON THE RESIN TIP OF THE FORCE FEEDBACK FENESTRATED BIPOLAR FORCEPS. THE PROCEDURE WAS CONTINUED AS PLANNED WITH NO REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH A NURSE FROM THE SITE AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE NURSE WAS NOT PRESENT FOR THE PROCEDURE. THE DAMAGE WAS DISCOVERED DURING PRE-OPERATIVE PREPARATIONS, BUT THE TIMING OF THE DAMAGE IS UNKNOWN. THERE WAS NO REPORT OF FRAGMENTS FALLING FROM THE DEVICE WHILE USED WITHIN A PATIENT. THE PATIENT HAS NOT RETURNED TO THE HOSPITAL DUE TO EXPERIENCING ANY POST-SURGICAL COMPLICATIONS RELATED TO RETAINING A FOREIGN OBJECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24866492 ↗
• MalfunctionFeb 24, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE FORCE FEEDBACK FENESTRATED BIPOLAR FORCEPS INSTRUMENT CAME APART PRIOR TO IT BEING USED. THERE WAS NO REPORT OF PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24437149 ↗
• InjuryFeb 23, 2026Material Fragmentation

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED SURGICAL PROCEDURE, THE TIP BROKE OFF ON THE FORCE FEEDBACK FENESTRATED BIPOLAR FORCEPS. A FRAGMENT FELL INTO THE PATIENT AND WAS RETRIEVED DURING THE SAME PROCEDURE. THE PROCEDURE WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24413747 ↗
• MalfunctionJan 23, 2026Unintended Movement

  IT WAS REPORTED THAT DURING A DA VINCI-ASSISTED HYSTERECTOMY SURGICAL PROCEDURE, THE FORCE FEEDBACK FENESTRATED BIPOLAR FORCEPS TIPS WOULD NOT OPEN. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24171441 ↗
• InjuryJan 8, 2026Material Fragmentation

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24016606 ↗
• MalfunctionDec 19, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING CENTRAL PROCESSING THE TECH NOTICED A SHARP FEELING. AFTER LOOKING UNDER THE CAMERA IT WAS NOTICED THAT THERE WAS FRAYING ON THE BLACK CABLE. THERE WAS NO REPORT OF PATIENT INVOLVEMENT OR REPORTED INJURY. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER ON AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE ISSUE WAS FOUND IN DIRTY DECONTAMINATION, AFTER THE CASE, WHILE CLEANING THE INSTRUMENT. THE TECH NOTICED SOMETHING WOULDN¿T COME OFF, SO USED THE CAMERA AND SAW THE FRAYING. THE INSTRUMENT WAS INSPECTED PRIOR TO USE. NO DAMAGE WAS NOTICED. THERE WAS NO LOSS OF CAUTERY. THERE WAS NO SIGNS OF THERMAL DAMAGE AT THE SIT OF INSULATION DAMAGE. THE INSTRUMENT DID NOT COLLIDE WITH ANY OTHER INSTRUMENT OR TOOL DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH THE SAME INSTRUMENT. NO FRAGMENT FELL INTO THE PATIENT DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23857357 ↗
• MalfunctionDec 17, 2025Break; Break

  IT WAS REPORTED THAT DURING CENTRAL PROCESSING, IT WAS NOTED THAT THE GRASPING TIP WAS BROKEN. THERE WAS NO REPORT OF PATIENT INVOLVEMENT OR REPORTED INJURY. INTUITIVE SURGICAL, INC. (ISI) FOLLOWED UP WITH THE INITIAL REPORTER AND OBTAINED THE FOLLOWING ADDITIONAL INFORMATION: THE INITIAL REPORTER SAID THERE WAS NO REPORTS OF FRAGMENT FALL ON THE PATIENT. THE ISSUE WAS IDENTIFIED DURING CENTRAL PROCESSING AND REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 23825196 ↗
• MalfunctionDec 12, 2025Break; Break

  IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE FORCE FEEDBACK INSTRUMENT SHAFT WAS BROKEN. THERE WAS NO REPORT OF PATIENT INVOLVEMENT OR REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 23786521 ↗
• MalfunctionDec 11, 2025Break; Break

  IT WAS REPORTED THAT THE FORCE FEEDBACK INSTRUMENT SHAFT WAS BROKEN. THERE WAS NO REPORT OF PATIENT INVOLVEMENT OR REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 23785135 ↗
• MalfunctionDec 11, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE INSTRUMENT WAS UNABLE TO BE REMOVED. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY.

  Patient problems: Insufficient Information

  MAUDE report 23785073 ↗
• MalfunctionDec 11, 2025No Apparent Adverse Event; No Apparent Adverse Event

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 23784088 ↗
• MalfunctionDec 11, 2025Break; Break

  IT WAS REPORTED THAT DURING CENTRAL PROCESSING, THE FORCE FEEDBACK INSTRUMENT SHAFT WAS BROKEN. THERE WAS NO REPORT OF PATIENT INVOLVEMENT OR REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 23784053 ↗
• MalfunctionDec 9, 2025No Device Output; No Device Output

  IT WAS REPORTED THAT THE OR STAFF CALLED TO REPORT AN ISSUE WITH FORCE FEEDBACK INSTRUMENTS, WHICH HAD ALREADY BEEN REPORTED IN A PREVIOUS SERVICE REQUEST. THE CALLER MENTIONED THAT THE SURGEON HAD TO TRY THREE DIFFERENT BIPOLAR FORCE FEEDBACK INSTRUMENTS, ALL OF WHICH WERE REJECTED, LEADING THE STAFF TO USE A NORMAL BIPOLAR INSTRUMENT TO CONTINUE THE PROCEDURE. THE CALLER DID NOT HAVE ADDITIONAL INFORMATION ABOUT THE ISSUE. THE TECHNICAL SUPPORT ENGINEER REVIEWED THE LOGS AND CONFIRMED THE ISSUE, ADVISING THAT ONE OF THE FORCE FEEDBACK INSTRUMENTS BE RETURNED FOR FAILURE ANALYSIS. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23761868 ↗
• MalfunctionNov 19, 2025No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT THE INSTRUMENT WAS BROKEN. THE CUSTOMER REPORTED EVENT HAS NO REPORT OF PATIENT INJURY. INTUITIVE SURGICAL, INC. (ISI) MADE MULTIPLE FOLLOW UP ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION, HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED AS OF DATE OF THIS REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23599712 ↗
• InjuryNov 7, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  REFER TO H11 FOR FOLLOW-UP INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 23498795 ↗